Obesity is a chronic disease due to excess fat storage, a genetic predisposition, and strong environmental contributions. This problem is worldwide, and the incidence is increasing daily. There are medical, physical, social, economic, and psychological comorbid conditions associated with obesity. There is no cure for obesity except possibly prevention. Non-surgical treatment has been inadequate in providing sustained weight loss. Currently, surgery offers the only viable treatment option with long-term weight loss and maintenance for the morbidly obese. Surgeries for weight loss are called bariatric surgeries. There is no one operation that is effective for all patients. Gastric bypass operations are the most common operations currently used. Because there are inherent complications from surgeries, bariatric surgeries should be performed in a multidisciplinary setting. The laparoscopic approach is being used by some surgeons in performing the various operations. The success rate—usually defined as >50% excess weight loss that is maintained for at least five years from bariatric surgery—ranges from 40% in the simple to >70% in the complex operations. The weight loss from surgical treatment results in significant improvements and, in some cases, complete resolution of comorbid conditions associated with obesity. Patients undergoing surgery for obesity need lifelong nutritional supplements and medical monitoring.
It is accepted that patients suffering from obesity are at a substantially increased risk of medical ailments and a range of diseases, including: Type II diabetes, heart disease, stroke, high blood pressure, high cholesterol, certain cancers, and other disorders. Furthermore, patients suffering morbid obesity have life expectancy that is significantly reduced, by at least ten to fifteen years.
For patients suffering from extremely severe obesity (morbid obesity), i.e. for patients whose weight exceeds the ideal weight by at least 50 kilograms, for example, it is absolutely essential to operate surgically on such patients in order to avoid not only a series of health problems that stem from such obesity, but also to avoid certain and imminent death of such patients.
It has also been observed that treatment based on a severe diet combined with a series of physical exercises associated with a change in behavior, in particular eating behavior, are relatively ineffective in such cases of morbid obesity, even though such methods of treatment are the most healthy.
Methods that have been used in the prior art to treat obesity include gastric bypasses and small-bowel bypasses such as described in U.S. Pat. No. 6,558,400 and U.S. Pat. No. 6,543,456. The number of these bariatric surgeries has skyrocketed from 40,000 per year back then to 120,000 in 2002. Many complications are associated with these procedures. Many patients have suffered serious side effects and regret having had it.
Other methods aim at reducing the effective volume of the stomach to induce a satiety feeling by the patient and hence reducing the calorie intake per meal.
One such method is the stapling of portions of the stomach has also been used to treat obesity, such as described in U.S. Pat. No. 5,345,949. This includes both vertical and horizontal stapling and other variations trying to reduce the size of the stomach or make a small stoma opening. Many problems have been associated with the use of staples. First, staples are undependable; second, they may cause perforations; and the pouch or stoma opening formed by the staples becomes enlarged over time making the procedure useless.
Another method that has been developed is the placement of an inflatable bag or balloon into the stomach causing the recipient to feel “full”. Such a procedure has been described in the patent to Garren et al U.S. Pat. No. 4,416,267. The balloon is inflated to approximately 80% of the stomach volume and remains in the stomach for a period of about three months or more. This procedure, although simple, has resulted in intestinal blockage, gastric ulcers, and even in one instance, death and fails to address the problems of potentially deleterious contact with the gastric mucosa which can result from leaving an inflated bag in the stomach for an extended period of time. Moreover, it also failed to produce significant weight loss for long periods of time.
Yet another method employs the placement of a band around a portion of the stomach thereby compressing the stomach and creating a stoma opening that is less than the normal interior diameter of the stomach for restricting food intake into the lower digestive portion of the stomach. Kuzmak et al in U.S. patent have described such a band. U.S. Pat. No. 4,592,339. It comprises a substantially non-extensible belt-like strap, which constrictively encircles the outside of the stomach thereby preventing the stoma opening from expanding. Kuzmak et al also describe bands, which include a balloon-like section that is expandable and deflatable through a remote injection site. The balloon-like expandable section is used to adjust the size of the stoma opening both intra-operatively and post-operatively.
Complications have been observed with both inflatable and non-inflatable gastric bands. In particular, obstruction of the stoma from edema and migration of the band has been observed. Such edema-caused obstruction of the stoma may be due to excessive vomiting. In these cases, the stoma must be enlarged either by deflating the expandable portion of a band or by removing the band altogether.
Yet another method is to impose satiety. U.S. Pat. No. 6,677,318, describing a swellable sponge-like structure. These structures are swallowed by the patient being collapsed inside a capsule. The capsule dissolves in the stomach and the polymer structure with super absorbing characteristics; absorb the gastric juices, which cause the structure to swell considerably. This patent aims to reduce food intake by causing the recipient to feel “full”, yet the absorbed content of the sponge is finally digested.
Lipase inhibition as a mean for reducing lipid intake is well known in the art, the major draw back is the oily stool as a side effect. To overcome this side effect, polymers capable of absorbing lipids where introduce, as in U.S. Pat. No. 4,432,968, but as the absorption is reversible and shifted backwards as a result of bile salt emulsifier, the overall entrapment was quite poor.
In order to overcome the a forth mentioned drawbacks, the present invention relates on a lipid absorption polymer having an prolonged equilibrium period in the range of 4-8 hours so as to keep the absorption step active during the relevant period in the digestion tract.
It is then the object of this invention to overcome these and other deficiencies described above.